Tools for DNA Diagnostics

ATP Focused Program Tools for DNA Diagnostics

NOTE: From 1994-1998, the bulk of ATP funding was applied to specific focused program areas—multi-year efforts aimed at achieving specific technology and business goals as defined by industry. ATP revised its competition model in 1999 and opened Competitions to all areas of technology. For more information on previously funded ATP Focused Programs, visit our website at http://www.atp.nist.gov/atp/focusprg.htm.

FY 1994 NIST Funding: $25 million
Total FY 1994-98 NIST-Funding: $145 million
Potential for U.S. Economic Benefit	Deoxyribonucleic acid (DNA) attained celebrity status among molecules in the 1950s when scientists first uncovered its now famous double helix structure. In the following decades, scientists began to show how the molecular basis of life flows from DNA. Since 1990, the National Institutes of Health and the Department of Energy have been funding a major effort -- called the Human Genome Project (HGP) -- to map out the thousands of individual genes strung along the 46 chromosomes in human cells and to sequence each gene. Each gene is made of four kinds of building blocks, called nucleotides, that link into linear sequences hundreds or thousands of nucleotides long. In the end, researchers hope to have mapped out the entire human genome, which is about 3 billion nucleotides long. Scientists and physicians expect that the HGP will prove to be a fountain of insights to now poorly understood biological phenomena and diseases and to new treatments for genetically based ailments. Industry -- the biotechnology sector and users of biotechnology's wares -- expects that it will become both the impetus and basis of new multibillion dollar markets stemming from DNA-based diagnostic tests. According to industry projections for 1997, the DNA-based portion of the in-vitro (outside of the body) diagnostics industry is expected to reach into the vicinity of $500 million of a total estimated market of well over $18 billion, up from a $58 million portion of an estimated $5 billion market in 1992. By 2005, DNA probes are expected to account for $6 billion, or 15 percent, of a $40 billion in-vitro diagnostics market. At the moment, the United States enjoys a lead position in this ever more global industry. That's where the ATP's focus on Tools for DNA Diagnostics comes in. According to representatives in the pharmaceutical, biotechnology, and analytical instrumentation industries, reaping the full potential of the HGP will require the development of new methods, instruments, and data-handling protocols. More specifically, DNA analyses and sequence interpretation will have to speed up by a factor of 10 and costs will have to fall to one-tenth to one-hundredth of the present price tag, which is in the range of $100 or more per test. Meeting these goals will help U.S. companies maintain their advantageous position in the coming years of the biotechnology revolution. The industries and technical arenas that stand to benefit from the program include *healthcare, forensics, biomedical research, environmental monitoring and bioremediation, toxicology, drug design, animal husbandry, agriculture, and quality control in the food industry*.
Technology Challenge	The initial goal of the Tools for DNA Diagnostics program is to develop cost-effective methods for sequencing, interpreting, and storing DNA sequences for diagnostic applications ranging from healthcare to agriculture to environmental monitoring. Moreover, these methods need to be highly automated, miniaturized whenever possible, easy to use, and inexpensive as well as able to determine and analyze DNA sequences accurately and rapidly. A working system meeting these criteria might begin with the injection of a sample into a cassette, which then would be positioned automatically into an instrument that performs the sequencing and stores the results. These results then could be displayed immediately on a computer screen and transferred to a patient's records. By the end of the five-year program, industry should have the technical tools and know-how in hand with which they can design, engineer, and produce commercial products like this one.
Industry Commitment	About 20 companies, which range in size from large established pharmaceutical firms to small start-up companies as well as non-profit research organizations, submitted the white papers from which DNA diagnostics emerged as an area that the biotechnology industry perceives to be badly in need of development. These papers made it clear that the program will require expertise in biological sample preparation, molecular biology, microfabrication, surface chemistry, instrumentation development and engineering, molecular detection technologies, information and data handling, and other areas. No single company can claim that it has all of those strengths, but a collection of companies, working toward common goals, can.
Significance of ATP Funds	A glimpse of what this focused program in Tools for DNA Diagnostics might mean comes from a current ATP project. The project involves the Genosensor Consortium, a group of companies that combines expertise in instrumentation, micro-electronics, chemical synthesis of DNA, and diagnostic test development. Without ATP funding, the risk would have been too high for the smaller consortium members to even consider pursuing the goals of the project. Larger members, whose stockholders may not be patient enough to wait for long-term payoff, also would likely have put the project on hold. The ATP program on DNA diagnostics can leverage existing government investments in DNA research to achieve the aim of low-cost DNA diagnostic technologies on a much larger scale. It can help U.S. industry to maintain its global leadership in the biotechnology industry. The HGP goes part of the way by supporting the research that produces the maps and sequences. But it does not support technology development for diagnostics, which ultimately must be more user friendly and automated than state-of-the-art instruments for basic research in the laboratory setting. At the moment, companies that are well positioned to develop DNA diagnostic tools are often hesitant to push forward without additional government support because any of a number of competing analytical methodologies could turn out to be the most suitable for DNA diagnostics. Betting on one technology, which is all that most companies could hope to do, is too much of a gamble. The ATP Tools for DNA Diagnostics program both reduces and dilutes that risk. The payoff could be the technology base for a new multibillion dollar industrial base in the United States that will keep the country on top in biotechnology and widen its scope of industrial applications.

Return to Brief Descriptions of Focused Programs

Return to Top of Page

Go to List of ATP Awards for Tools for DNA Diagnostics

Date created: 1994
Last updated: April 12, 2005

ATP website comments: webmaster-atp@nist.gov / Technical ATP inquiries: InfoCoord.ATP@nist.gov

NIST is an agency of the U.S. Commerce Department
Privacy policy / Security Notice / Accessibility Statement / Disclaimer / Freedom of Information Act (FOIA) /
No Fear Act Policy / NIST Information Quallity Standards / ExpectMore.gov (performance of federal programs)